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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003892-35 | EudraCT Number |
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The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling. |
|
| Acaroid | Experimental | The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acaroid | Biological | The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Inhalative dose of fluticasone propionate | The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation. | After 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-bronchodilator morning peak flow | Post treatment, the changes from baseline in the mean pre-bronchodilator morning peak flow during the last two weeks of the diary phases were determined. | After 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annemie Narkus, M.D. | Allergopharma GmbH & Co. KG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergopharma GmbH & Co. KG | Reinbek | 21465 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20624650 | Result | Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10. |
| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
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| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
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| Placebo | Drug | Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling. |
|
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| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |